ONK — Oral Lubricant Class I
FDA product code ONK covers "Oral Lubricant", a Class I medical device regulated under 21 CFR 880.6375. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ONK
- Device Class
- Class I
- Regulation Number
- 880.6375
- Submission Type
- Review Panel
- DE
- Medical Specialty
- General Hospital
- Implant
- No
Definition
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090457 | pulpdent corporation | ORALUBE | May 21, 2009 |